BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834340 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-07057
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2012-07056. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND THE RIGHT CORONARY ARTERY (RCA). PLAQUE IN THE RCA WAS PREDILATED WITH A 2.0X12MM MAVERICK BALLOON. THE PHYSICIAN IMPLANTED 2 (2.5X28MM AND 2.25X16MM) PROMUS ELEMENT STENTS IN THE LESION. THEN THE PHYSICIAN USED A 6 FRENCH GUIDING CATHETER AND A NON-BSC GUIDE WIRE IN THE LESION IN THE LAD. PLAQUE IN THE MID LAD WAS OPENED WITH A NON-BSC 2.5X15MM BALLOON. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION USING A 2.5X38MM PROMUS ELEMENT STENT BUT WAS UNABLE TO CROSS THE LESION. "THE PLAQUE EMBOLISED HAPPENED DUE TO WHICH THE B.P. OF THE PATIENT DECREASED DRASTICALLY AND THE PATIENT CRASHED." THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death BMW GUIDE WIRE| 2.0X12MM MAVERICK2| 2.5X28MM PROMUS ELEMENT